Your comprehensive resource for understanding 503A vs 503B compounding, selecting the right therapies, and navigating the regulatory landscape with confidence.
Why it matters for clinics, med spas, telehealth brands, and pharmacies
In the compounding world, two key regulatory paths exist under the Food & Drug Administration (FDA) — Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Knowing the difference helps you choose the right partner and provides peace of mind in sourcing.
"Section 503A of the FD&C Act applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility under section 503B."
Traditional Pharmacy
Patient-Specific Prescriptions
Requires valid prescription for individual patient
Smaller Scale Operations
Typically prepares medications in smaller batches
State Pharmacy Regulation
Primarily regulated by state pharmacy boards
FDA Exemptions Available
Certain exemptions from FDA drug approval requirements
USP Standards
Follows USP compounding chapters (795, 797, 800)
Outsourcing Facility
Larger Scale / Office Use
Can produce bulk batches for clinic office use
FDA Registration Required
Must register with FDA as outsourcing facility
Full CGMP Requirements
Must comply with Current Good Manufacturing Practices
FDA Inspections
Subject to regular FDA facility inspections
Adverse Event Reporting
Must report adverse events to FDA
At Access503, we partner only with pharmacies and facilities that are appropriately designated as 503A or 503B, ensuring your sourcing is aligned with the right regulatory framework. Every partner undergoes rigorous verification to meet our quality and compliance standards.
Know what to look for when evaluating a compounding pharmacy or outsourcing facility
FDA-registered outsourcing facility if claiming 503B status. Verify registration on FDA's website.
503B facilities must follow Current Good Manufacturing Practices; 503A pharmacies follow USP chapters 795, 797, and 800.
Verified documentation of active pharmaceutical ingredient purity, potency, and identity from reputable suppliers.
Based on stability data, not arbitrary timelines. Should follow USP guidelines and be backed by testing.
Clear documentation about bulk drug substances and FDA "bulk list" eligibility. Willingness to share supply chain details.
Documented sterile processes, environmental monitoring, and regular testing for sterile preparations.
Compounding versions of commercially available FDA-approved drugs without clinical justification is prohibited.
Operations without proper pharmacy licenses or FDA registration (for 503B) are illegal and dangerous.
Injectable medications require sterile compounding in controlled environments (ISO Class 5 or better).
Products labeled for research purposes should never be used clinically. This is a major compliance violation.
No CoAs, stability data, or testing records. Refusal to provide supply chain transparency is a major warning sign.
Clinical use requires pharmaceutical-grade (USP) ingredients. Food or lab-grade materials are not appropriate.
We conduct comprehensive evaluations of every pharmacy and outsourcing facility in our network, ensuring they meet or exceed all regulatory requirements and quality standards.
Connect with Verified PartnersExplore the top 21 therapies providers are asking about — learn which ones ideally come from a pharmacy vs. outside sources, and what you should check for.
GLP-1 receptor agonist for weight management and metabolic support
⚠ Compounding "Essentially a Copy" Restricted
Medical necessity and/or significant differences in formulation, dosage, or delivery method may create pathway for compounding. Verify current FDA shortage status and clinical justification.
Dual GLP-1/GIP receptor agonist for metabolic health
⚠ Compounding "Essentially a Copy" Restricted
Removed from FDA shortage list (Oct 2024). Medical necessity and/or significant differences in formulation, dosage, or delivery method may create pathway for compounding.
Growth hormone releasing hormone (GHRH) analogue peptide therapy
✓ Licensed Compounding Pharmacy
Peptide therapy with established compounding protocols
Body Protection Compound peptide for tissue repair and recovery
⚠ Not FDA-Approved; Investigational
Not approved for any medical use; compounding requires careful regulatory consideration
Master antioxidant for wellness and detoxification support
✓ Licensed Compounding Pharmacy
Ensure pharmaceutical-grade quality and proper sterility
Nicotinamide adenine dinucleotide for cellular energy and longevity
✓ Licensed Compounding Pharmacy
Wellness injectable requiring quality sourcing verification
Hormone replacement therapy via licensed pharmacy
✓ Licensed 503A Pharmacy (Patient-Specific)
Controlled substance requiring DEA compliance
Copper peptide for skin regeneration and anti-aging
✓ Licensed Compounding Pharmacy
Popular peptide in aesthetic and wellness applications
Growth hormone releasing hormone (GHRH) analog peptide
✓ Licensed Compounding Pharmacy
Often combined with Ipamorelin for synergistic effects
Growth hormone secretagogue peptide therapy
✓ Licensed Compounding Pharmacy
Selective GH secretagogue with favorable safety profile
Immune modulating peptide for wellness support
✓ Licensed Compounding Pharmacy
Requires pharmaceutical-grade synthesis and verification
Tissue repair and regeneration peptide (TB-500)
⚠ Not FDA-Approved for Human Use
Not approved for medical use; compounding limited by regulatory framework
Melanocortin receptor agonist for wellness applications
⚠ FDA-Approved Drug; Compounding Restrictions
Available as Vyleesi (FDA-approved); compounding as "essentially a copy" requires clinical justification
Melanocortin peptide (clinical use requires oversight)
⚠ Clinical Oversight Required
Only through licensed pharmacy with proper prescriber guidance
Modified growth hormone fragment peptide
✓ Licensed Compounding Pharmacy
Body composition peptide with metabolic focus
Mitochondrial-derived peptide for metabolic health
✓ Licensed Compounding Pharmacy
Emerging longevity peptide requiring quality sourcing
Tetrapeptide for cellular health and longevity
✓ Licensed Compounding Pharmacy
Longevity-focused peptide with emerging clinical interest
Nootropic peptide for cognitive and mood support
✓ Licensed Compounding Pharmacy
Requires appropriate clinical oversight and patient selection
Neuropeptide for cognitive enhancement and brain health
✓ Licensed Compounding Pharmacy
Cognitive health peptide with specific delivery requirements
Injectable for joint health and musculoskeletal support
✓ Licensed 503A or 503B Pharmacy
Compounded formulation for orthopedic applications
Nootropic peptide for cognitive enhancement and neuroplasticity
✓ Licensed Compounding Pharmacy
Advanced cognitive peptide requiring pharmaceutical-grade sourcing
Access503 partners with verified facilities offering physician-supervised programs and compounded peptides including BPC-157, GHK-Cu, NAD+, and comprehensive weight management solutions.
All partner facilities undergo rigorous verification for licensing, quality standards, and regulatory compliance.
Comprehensive access to verified compounded medications across all major therapeutic categories
Compounded Semaglutide and Tirzepatide for weight management and metabolic health through licensed 503A and 503B pharmacies.
Comprehensive peptide portfolio including Sermorelin, GHK-Cu, BPC-157, NAD+, and specialized longevity peptides.
Compounded Testosterone, Estrogen, Progesterone, and bioidentical hormone therapies via licensed pharmacies.
IV/IM therapies including Glutathione, NAD+, vitamin complexes, and lipotropic wellness blends.
503B outsourcing facility options for pharmacies and clinics requiring office-use bulk preparations.
Verified pharmaceutical-grade active pharmaceutical ingredients with complete chain-of-custody documentation.
Because we know the landscape: decades of pharmacy, compounding, supply-chain, and regulatory experience. We help you navigate 503A vs 503B, evaluate facilities, ensure quality APIs and state compliance, and choose the right product category for your practice or facility.
Both 503A & 503B facilities thoroughly vetted for compliance
Complete documentation and verification of all ingredients
Navigate complex jurisdiction-specific regulations
Comprehensive resources like this page and ongoing support
From provider to pharmacy to patient or clinic
Find the right pathway for your practice or organization